Spots Global Cancer Trial Database for Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

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Trial Identification

Brief Title: Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Official Title: A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Study ID: NCT05565417

Conditions

Non Small Cell Lung Cancer

Head and Neck Squamous Cell Carcinoma

Triple Negative Breast Cancer

Cutaneous Squamous Cell Carcinoma

Hormone Receptor Positive Breast Carcinoma

Small Bowel Cancer

Esophageal Cancer

Colorectal Cancer

Diffuse Large B Cell Lymphoma

Hodgkin Lymphoma

Burkitt Lymphoma

Follicular Lymphoma

Interventions

IMT-009

Fruquintinib

Study Description

Brief Summary: This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: * Find the recommended dose of IMT-009 that can be safely given to participants * Learn more about the side effects of IMT-009 * Learn more about pharmacokinetics of IMT-009 * Learn more about the effectiveness of IMT-009 * Learn more about different pharmacokinetic biomarkers and how they might change in the presence of IMT-009

Detailed Description: IMT-009 is an Fc-attenuated monoclonal antibody that binds with high affinity and selectivity to CD161, a receptor that is broadly expressed on NK and a subset of memory T cells, blocking interactions between the receptor and its cognate ligand, CLEC2D, which is expressed on the surface of both cancer cells and immune cells. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. This is a Phase 1/2a, open label dose escalation study of IMT-009, a fully human monoclonal antibody targeting CD161, given as a single agent in Phase 1 and potentially in combination with other antineoplastic agents in Phase 2.